Trial record 7 of 4451 for:    Pregnancy

Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01084941
First received: March 9, 2010
Last updated: November 20, 2013
Last verified: July 2013
  Purpose

The prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight and obesity when they become pregnant, experience higher rates of excessive weight gain during pregnancy, and experience higher rates of maternal and neonatal complications after adjusting for sociodemographic characteristics and comorbidities than Caucasian women. Epidemiologic studies indicate that lifestyle modification programs based on diet and exercise are promising approaches in controlling weight gain as well as in preventing type 2 diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet and moderate exercise will result in higher compliance with Institute of Medicine guidelines for weight gain than women receiving standard care. Such lifestyle modifications should reduce risk of maternal and neonatal complications. We propose 1) to determine whether a lifestyle intervention program, based on diet and moderate physical activity implemented shortly after first recognition of pregnancy, will result in higher compliance with Institute of Medicine guidelines for weight gain compared to women receiving standard care; 2) to determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the lifestyle intervention group and women receiving standard care; and 3) to explore the impact of the lifestyle intervention on the development of maternal and fetal complications during pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent the burden of obesity-related complications during pregnancy and reduce risk of subsequently developing overt diabetes.


Condition Intervention Phase
Pregnancy
Weight Gain
Behavioral: Lifestyle Intervention group
Behavioral: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The primary outcome is whether a woman's weight gain follows the Institute of Medicine's recommendations for pregnancy weight gain. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation and after delivery between women in the lifestyle intervention group and women receiving standard care. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • To explore the impact of the lifestyle intervention in preventing maternal and fetal complications between women in the lifestyle intervention group and women receiving standard care. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle intervention
Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks.
Behavioral: Lifestyle Intervention group
Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks.
Active Comparator: Standard of care group
Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy.
Behavioral: Standard of Care
Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Blacks and Hispanic
  • women between 18-45 years of age;
  • 2) overweight and obese (BMI > 25 kg/m2),
  • 3) have a sedentary lifestyle (<30 minutes/day of moderate physical activity), and
  • 4) prenatal care established at less than 20 weeks of gestation,
  • 5) with a singleton pregnancy.

Exclusion Criteria:

  • Women with 1) age < 18 or > 45 years,
  • 2) > 20 weeks gestation,
  • 3) history of diagnosis of type 2 diabetes, hypertension, cardiovascular disease, chronic renal disease, and active liver disease (AST > 3 ULN),
  • 4) anemia (hemoglobin < 10 g, hematocrit < 32%);
  • 5) current medications which adversely influence glucose tolerance (corticosteroids),
  • 6) multiple pregnancy,
  • 7) women not planning to continue pregnancy to term, 7) contraindications to participate in regular physical activity,
  • 8) patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084941

Locations
United States, Georgia
Grady Memorial Hospital
Atlant, Georgia, United States, 30303
Sponsors and Collaborators
Guillermo Umpierrez
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01084941     History of Changes
Other Study ID Numbers: IRB00030742
Study First Received: March 9, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pregnancy
weight gain
obesity
pregnancy and weight gain

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014